DK162922B - STORAGE AND DELIVERY SYSTEM, ISAES FOR MEDICINE - Google Patents

STORAGE AND DELIVERY SYSTEM, ISAES FOR MEDICINE Download PDF

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Publication number
DK162922B
DK162922B DK104485A DK104485A DK162922B DK 162922 B DK162922 B DK 162922B DK 104485 A DK104485 A DK 104485A DK 104485 A DK104485 A DK 104485A DK 162922 B DK162922 B DK 162922B
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DK
Denmark
Prior art keywords
bottle
port
skirt
stopper
diaphragm
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DK104485A
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Danish (da)
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DK104485D0 (en
DK162922C (en
DK104485A (en
Inventor
Edward S Tripp
Mark E Larkin
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Abbott Lab
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10—Bag-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1475—Inlet or outlet ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2041—Separating means having removable plugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2065—Connecting means having aligning and guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents

Abstract

A stoppered drug vial forms part of a drug delivery system which maintains the sterility of the drug in storage, dilution and use. A removable, pierceable diaphragram is placed over the stopper which seals the vial. The removable, pierceable diaphragm is held in place by attachment to a skirt member which encloses and is in frictional contact with the upper portion of the vial wall. Access to the drug in the vial may be obtained by either removing the diaphragm and the stopper or piercing the diaphragm and the stopper with a cannula.

Description

iin

DK 162922 BDK 162922 B

Den foreliggende opfindelse angår et lager- og leveringssystem af den i krav l's indledning angivne art. Systemet både lagrer og giver derefter mulighed for steril adgang til en lille medicinflaskes indhold. Specielt angår den foreliggende opfin-5 delse et medicinleveringssystem, der også giver mulighed for steril adgang til et emballeret lægemiddel, enten ved at benytte en sprøjte eller ved direkte at indsætte flasken med me-dici nindhold i en fluidumtilførselskilde i et i ntravenøst i ndg i ftsystem.The present invention relates to a storage and delivery system of the kind set forth in claim 1. The system both stores and then allows sterile access to the contents of a small medicine bottle. Specifically, the present invention relates to a drug delivery system which also allows for sterile access to a packaged drug, either by using a syringe or by directly inserting the drug-containing bottle into a fluid supply source into a ntravenous drug. ftsystem.

1010

Medikamenter eller lægemidler, der normalt indgives i et sundhedsplejemiljø, er, da de er flydende substanser, typisk emballeret i små medicinflasker, hvis indre holdes i en steril tilstand. Disse små medicinflasker er selv forseglede ved 15 hjælp af en steril prop, der til slut gennembrydes ved en kanyle, når det ønskes at fjerne medikamentet eller lægemidlet. Flere procedurer er nødvendig for at få lægemidlet fra den lille medicinflaske og ind i en patients legeme. Hver procedure er tidsrøvende for plejepersonalet og endnu mere vigtigt 20 er det, at hver procedure medfører en risiko for at sætte medicinflaskens, proppens eller lægemidlets sterilitet over styr.Medicines or drugs that are usually administered in a healthcare environment are, as they are liquid substances, typically packaged in small medicine bottles whose interiors are kept in a sterile state. These small vials are themselves sealed by a sterile plug which is finally pierced by a cannula when it is desired to remove the drug or drug. More procedures are needed to get the drug from the small medicine bottle into a patient's body. Each procedure is time-consuming for the caregiver and even more important is that each procedure carries a risk of compromising the sterility of the medicine bottle, stopper or drug.

Hvis lægemidlet i en speciel medicinflaske er et pulver, om-25 fatter de procedurer, der kan sætte steriliteten over styr, tilsætning af diluenda til medicinflasken for at opløse pulveret og derpå yderligere fortynde den koncentrerede diluen-da/medicinopløsning til den ønskede styrke. Når medicinen eller lægemidlet kan indgives en patient direkte, kan man benyt-30 te en kanyle eller sprøjte til at foretage en indsprøjtning gennem patientens hud eller ind i et Y-sted i et intravenøst indgiftsæt. Hvis medicinen eller lægemidlet har en sådan styrke, at det skal indgives over en forlænget ti dsperi ode, blandes medicinen eller lægemidlet med en stor mængde diluenda og 35 anbringes i en beholder, der bliver en sekundær fluidumkilde i et båret intravenøst indgiftsystem. Hvis der ikke er nogen primær fluidumkilde i et intravenøst indgiftsystem kan medici-If the drug in a particular medicine bottle is a powder, the procedures that can control sterility include adding diluents to the medicine bottle to dissolve the powder and then further diluting the concentrated diluent / drug solution to the desired strength. When the drug or drug can be administered to a patient directly, a cannula or syringe can be used to inject through the patient's skin or into a Y site in an intravenous administration kit. If the drug or drug has such strength as to be administered over an extended period of time, the drug or drug is mixed with a large amount of diluent and placed in a container which becomes a secondary source of fluid in a carried intravenous administration system. If there is no primary fluid source in an intravenous administration system, medication may be

DK 162922 BDK 162922 B

2 nen og di 1uendaopløsningen selv indgives en patient intravenøst .The patient and the patient solution themselves are administered intravenously to a patient.

Det af plejepersonale og farmaceuter med kendte medicinindgiv-5 ningssystemer mødte problem har derfor to sider. For det første kræves flere tidsrøvende procedurer for at bringe lægemidlet fra dets lagertilstand til en tilstand, i hvilken det korrekt og sikkert kan indgives en patient. For det andet medfører hver procedure mellem lagring og indgift en ny mulighed 10 for at sætte lægemiddelproppen eller -flaskens sterilitet over styr. Der er derfor et behov for at tilvejebringe et system, ved hvilken muligheden for forurening af et lægemiddel, medicinflasken og proppen mellem lager og indgift bringes til et minimum.Therefore, the problem encountered by nursing staff and pharmacists with known drug administration systems has two sides. First, several time-consuming procedures are required to bring the drug from its storage state to a state in which it can be properly and safely administered to a patient. Second, each procedure between storage and administration provides a new opportunity 10 to control the sterility of the drug stopper or vial. Therefore, there is a need to provide a system whereby the possibility of contamination of a drug, the medicine bottle and stopper between storage and administration is minimized.

15 US patentskrift nr. 2.977.014 beskriver en lille medicinflaskes indeslutning i en særskilt beholder for beskyttelse mod beskadigelse, US patentskrift nr. 3.394.831 beskriver desuden en afrivningsstrimmel for at gøre det lettere at åbne en be-20 skyttende emballage, der omgiver en medicinbeholder. Anvendelsen af en U-formet prop til sikkert at låse og åbne en medicinflaskes åbning er beskrevet i US patentskrift nr. 2.746.632. Tildækning af medicinflaskens prop med en forseglende skive for at bevare proppens sterilitet er beskrevet i 25 US patentskrift nr. 4.244.478, og dannelsen af et håndtag eller et ophængningsorgan ved beholderens basis er beskrevet i US patentskrift nr. 3.325.031.U.S. Patent No. 2,977,014 discloses the enclosure of a small medicine bottle in a separate container for damage protection, U.S. Patent No. 3,394,831 further discloses a tear-off strip to facilitate opening a protective package surrounding a medicine container. The use of a U-shaped plug for securely locking and opening the opening of a medicine vial is described in U.S. Patent No. 2,746,632. Covering the medicine bottle stopper with a sealing disk to preserve the sterility of the stopper is disclosed in U.S. Patent No. 4,244,478, and the formation of a handle or suspension member at the base of the container is disclosed in U.S. Patent No. 3,325,031.

Intet steds inden for den kendte teknik findes et medicinleve-30 ringssystem, der reducerer procedurerne mellem lagring og indgift til et minimum, og som samtidig sikrer lægemidlets, proppens og medicinflaskens sterilitet og det er den foreliggende opfindelses formål at opnå denne sikring af steriliteten.Nowhere in the prior art is there a drug delivery system that minimizes storage and administration procedures while at the same time ensuring the sterility of the drug, stopper and medicine vial and it is the object of the present invention to achieve this assurance of sterility.

35 Dette formål opnås ved, at det indledningsvis omtalte system ifølge opfindelsen er ejendommelig ved det i den kendetegnende del af krav 1 anførte. Herved sikres sterilitet under lagring og klargøring, idet det på en enkel og hurtig måde bliver mu ligt trinvist at fjerne lukkedelene uden at komme i berøring med kritiske dele af systemet.This object is achieved by the fact that the system of the invention mentioned in the introduction is characterized by the characterizing part of claim 1. This ensures sterility during storage and preparation, in a simple and quick way it is possible to stepwise remove the closure parts without coming into contact with critical parts of the system.

33

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5 Ved den foreliggende opfindelse anvises således et system til lagring og levering af et lægemiddel eller medicin til brug for plejepersonale eller farmaceuter. Lægemidlet eller medicinen er forseglet i medicinflasken ved hjælp af en aftagelig gennembrydelig prop i flaskeåbningen. I flaskeåbningen er der 10 over proppen placeret en aftagelig gennembrydelig membran.Accordingly, the present invention provides a system for storing and delivering a drug or medicine for use by nursing staff or pharmacists. The drug or medicine is sealed in the medicine bottle by means of a removable permeable plug in the bottle opening. In the bottle opening, a removable permeable membrane is placed over the cap.

Forløbende rundt om flaskens yderside er der en skørtdel, der er i friktionsmæssig berøring med flaskens vægpart. Membranen er forbundet til skørtdelen, således at adgang til flaskens indre kan opnås ved enten at bryde membranen og proppen med en 15 kanylespids eller fuldstændigt at fjerne membranen fra skørtdelen, således at proppen kan fjernes fra flaskeåbningen, I den foretrukne udførelsesform gennemføres membranens adskillelse fra skørtdelen ved at benytte skrøbelige sektioner, der forløber rundt om den part af skørtdelen, der forbinder skør-20 tedelparten, der er i friktionsmæssig berøring med flaskens vægpart og membranen. Når først membranen er blevet fjernet fra sin placering over proppen, kan proppen fjernes fra den lille medicinflaske og flaskens indhold tilsættes til et intravenøst indgiftsystem uden at kompromittere lægemidlets, 25 flaskens eller proppens sterilitet. Et system der beskriver et apparat til direkte at tilsætte en medicin eller et lægemiddel til en fleksibel beholder for endelig brug som enten en primær eller sekundær fluidumkilde ved intravenøs terapi er beskrevet i US-patentskrift nr. 4.614.267.Proceeding around the outside of the bottle there is a skirt portion that is in frictional contact with the wall portion of the bottle. The diaphragm is connected to the skirt portion so that access to the bottle interior can be achieved by either breaking the diaphragm and cap with a needle tip or completely removing the diaphragm from the skirt portion so that the cap can be removed from the bottle opening. In the preferred embodiment, the diaphragm separation from the skirt portion is performed. by using fragile sections extending around the portion of the skirt portion connecting the skirt portion which is in frictional contact with the wall portion of the bottle and the diaphragm. Once the diaphragm has been removed from its location above the stopper, the stopper can be removed from the small vial and the contents of the vial added to an intravenous administration system without compromising the sterility of the drug, vial or stopper. A system describing an apparatus for directly adding a drug or drug to a flexible container for final use as either a primary or secondary fluid source in intravenous therapy is described in U.S. Patent No. 4,614,267.

3030

Medicinleveringssystemet ifølge opfindelsen forklares nærmere nedenfor under henvisning til tegningen, hvori f i g. 1 er et perspektivbillede af medicinleveringssystemet 35 ifølge opfindelsen, 4The drug delivery system according to the invention is explained in more detail below with reference to the drawing, wherein f in g. 1 is a perspective view of the drug delivery system 35 according to the invention, 4

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fig. 2 viser set fra siden med i c i n1 ever i ngssysternet ifølge opfindelsen i forbindelse med et entravenøst indgiftsystem, fig. 3 er et delsnit set forfra af medicinleveringssystemet 5 illustreret i fig. 1, fig. 4 er et sprængbillede af medicinleveringssystemet illu-· streret i fig. 1, 10 fig. 5 er et snit gennem medicinleveringssystemet ifølge opfindelsen i brug i forbindelse med en sprøjte, fig. 6 er et perspektivbillede af medicinleveringssystemet ifølge opfindelsen illustrerende aftagning af afrivningshætten, 15 fig. 7 viser set fra siden i delsnit medicinleveringssystemet ifølge opfindelsen indsat i en port på en fleksibel diluenda-beholder, 20 fig. 8 viser set fra siden og i delsnit medicinleveringssystemet ifølge opfindelsen i fluidumforbindelse med diluendaet i en fleksibel diluendabeholder, og fig. 9 er et spramgbiIlede af en anden udførelsesform for 25 medicinleveringssystemet ifølge opfindelsen.FIG. Figure 2 is a side view of the c system of the present invention in connection with an intravenous administration system; 3 is a front elevational sectional view of the drug delivery system 5 illustrated in FIG. 1, FIG. 4 is an exploded view of the drug delivery system illustrated in FIG. 1, 10 FIG. 5 is a section through the drug delivery system of the invention in use in conjunction with a syringe; FIG. 6 is a perspective view of the drug delivery system according to the invention illustrating removal of the tear-off cap; FIG. 7 is a side view of the partial section of the drug delivery system of the invention inserted into a port of a flexible diluent container; FIG. Figure 8 is a side elevational and partial sectional view of the drug delivery system of the invention in fluid communication with the diluent of a flexible diluent container; 9 is a fragmentary view of another embodiment of the drug delivery system of the invention.

Pig. 1 illustrerer den foretrukne udførelsesform for et medicinleveringssystem 10 ifølge opfindelsen, således som det vil blive modtaget af plejepersonalet eller hospitalsapoteket.Pig. 1 illustrates the preferred embodiment of a drug delivery system 10 according to the invention, as will be received by the nursing staff or hospital pharmacist.

30 Medicinen identificeres over for forbrugeren ved hjælp af en etikette 48. Svøbdelen 54 og skørtdelen 46 danner en muffe, der omgiver den lille flaske 26, der indeholder medicin (fig. 3 og 4). En afrivningsstrimmel 40 er formet i ét med skørtdelen 46, hvilken afrivningsstrimmel kan fjernes fra 35 systemet 10 ved at gribe fligen 42. Når først afrivningsstrimme-len 40 er blevet fjernet, kan en gennembrydelig membran 32 også fjernes for derved at frilægge den lille medicinflaske 26's top. Når membranen 32, afrivningsstrimmelen 40 og skørtdelen 46 er på plads, holder disse de øvre parter af flasken 26 og proppen 28 (fig. 3 og 4) i steril tilstand.The medicine is identified to the consumer by a label 48. The wrapper portion 54 and the skirt portion 46 form a sleeve surrounding the small bottle 26 containing medicaments (Figures 3 and 4). A tear-off strip 40 is formed integrally with the skirt portion 46, which tear-off strip can be removed from the system 10 by gripping tab 42. Once the tear-off strip 40 has been removed, a permeable membrane 32 can also be removed thereby exposing the small medicine bottle 26 top. When the diaphragm 32, the stripping strip 40 and the skirt portion 46 are in place, they hold the upper portions of the bottle 26 and the stopper 28 (Figs. 3 and 4) in sterile condition.

55

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Som det vil blive forklaret nærmere neden for kan systemet 10 også benyttes med en standardsprøjte 12 (fig. 5), når først en afpillelig forsegling 66 er blevet fjernet. I fig. 2 ses systemet 10 som en del af en fluidumkilde 16, der typisk er 5 en fleksibel beholder, der yderligere er forbundet til en slange 18 og et kateter eller en kanyle 20 for intravenøs indgift af medicin og diluenda til en patient. I denne driftsform ses nødvendigheden af at holde medicinflasken 26's toppart og proppen 28 i steril tilstand bedst, da flasken 26's hals 10 27 er ganske tæt ved diluendaet i den fleksible beholder 16 (fig. 7).As will be explained in more detail below, the system 10 can also be used with a standard syringe 12 (Fig. 5) once a peelable seal 66 has been removed. In FIG. 2, system 10 is viewed as part of a fluid source 16, typically 5 a flexible container, further connected to a tube 18 and a catheter or cannula 20 for intravenous administration of medication and diluents to a patient. In this mode of operation, the necessity of holding the top portion of the medicine bottle 26 and the stopper 28 in sterile condition is best seen as the neck 10 27 of the bottle 26 is quite close to the diluent of the flexible container 16 (Fig. 7).

Systemet 10's konstruktion, hvorved bevarelse af sterilitet og betjening lettes, fremgår især af fig. 3 og 4. En flaske *5 26 benyttes til at indeholde en substans, der kan strømme, såsom en medicin 56 i pulver- eller væskeform. Selvom der er vist en cirkulær flaske 26 med en konisk hals 27 er det indlysende, at medicinflaskens form ikke er af kritisk betydning for, at systemet ifølge opfindelsen kan virke.The construction of the system 10, which facilitates the preservation of sterility and operation, is particularly apparent from FIG. 3 and 4. A bottle * 5 26 is used to contain a substance which can flow, such as a powder or liquid medicine 56. Although a circular bottle 26 with a conical neck 27 is shown, it is obvious that the shape of the medicine bottle is not of critical importance for the system of the invention to operate.

2020

En aftagelig, gennembrydelig prop 28 forsegler flasken 26's åbning 58 og bevarermedicinen 56's sterilitet. Proppen 28 er fortrinsvis i det væsentlige U-formet, idet den har en nedtrykning 30, der er orienteret således, at U-formens bund *5 vender hen imod medicinen 56 og U-formens arme tætner mod åbningen 58. Det må forstås, at enhver propkonstruktion, såsom en der indbefatter et fremspring, der står ud fra proppen og som letter proppens aftagelse kan benyttes i stedet for den viste U-formede konstruktion.A removable, permeable plug 28 seals the opening 58 of the bottle 26 and the sterility of the preservative medicine 56. The plug 28 is preferably substantially U-shaped, having a depression 30 oriented such that the bottom * 5 of the U-shape faces the medicine 56 and the arms of the U-shape close to the opening 58. It should be understood that any plug structure, such as one including a protrusion projecting from the plug and facilitating the removal of the plug can be used in place of the U-shaped structure shown.

30 I den foretrukne udførelsesform har flasken 26's top gevind 64, der forløber rundt om åbningen 58's ydre part. Alternativt kan man benytte en ikke-gevindskåren flaske 26 eller en flaske, hvis afslutning indbefatter en rundtgående ring.In the preferred embodiment, the top thread 64 of the bottle 26 has extending around the outer portion of the opening 58. Alternatively, a non-threaded bottle 26 or a bottle may be used, the end of which includes an annular ring.

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66

Placeret over proppen er der en aftagelig gennembrydelig membran 32. Porløbende ned fra den gennembrydelige membran 32's sider er der en forbindelsessektion 34. Forbindelsessektionen 34 ender ved en skør eller skrøbelig sektion 36, der forløber 5 rundt om forbindelsessektionen 34. Selvom en skrøbelig sektion 36 er vist i forbindelse med den foretrukne udførelsesform er dens tilstedeværelse ikke af kritisk betydning for den foreliggende opfindelses funktion. Alternativt kan enhver form for svækket sektion benyttes. Om ønsket, kan man benytte 10 en anden skrøbelig sektion 38 til at danne en afrivningsstrimmel 40, der forløber rundt om forbindelsessektionen 34 og flasken 26's hals 27.Located above the plug is a removable permeable membrane 32. Pore running down from the sides of the permeable membrane 32 is a connecting section 34. The connecting section 34 ends at a brittle or fragile section 36 extending 5 around the connecting section 34. Although a fragile section 36 is shown in connection with the preferred embodiment, its presence is not critical to the function of the present invention. Alternatively, any type of weakened section may be used. If desired, another fragile section 38 may be used to form a tear strip 40 extending around the connecting section 34 and the neck 27 of the bottle 26.

Fra afrivningsstrimmelen 40 forløber en skørtdel 46 ned langs 15 flaskens 26 vægpart 60, hvilken skørtdel ligesom forbindel-sektionen 34 forløber rundt om flasken 26. På skørtdelen 46's inderside findes ribbedele 50 og 52, der er i friktionsmæssigt indgreb med flasken 26's vægpart 60. Medens ribbedelene 50 og 52 er vist i forbindelse med den foretrukne udførelses-20 form for systemet 10 er deres tilstedeværelse ikke af kritisk betydning for den foreliggende opfindelses funktion. Alternativt kan skørtdelen 46 være i direkte kontakt med enten flasken 26's hals 27 eller vægpart 60. I den foretrukne udførelsesform danner ribbedelene 50 og 52 en barriere til at bevare halsen 27, gevindene 64 og proppen 28 i en steril tilstand. Følgelig holdes den gennembrydelige membran 32 på plads over proppen 28 ved at være formet i ét med forbindelsessektionen 34, der igen er formet i ét med skørtdelen 46, der er i friktionsmæssigt indgreb med flasken 26's yægpart 60.From the stripping strip 40, a skirt portion 46 extends down the wall portion 60 of the bottle 26, which skirt portion, like the connecting section 34, extends around the bottle 26. On the inside of the skirt portion 46 are rib portions 50 and 52 which are frictionally engaged with the wall portion 60 of the bottle 26. The rib parts 50 and 52 are shown in connection with the preferred embodiment of the system 10, their presence is not critical to the function of the present invention. Alternatively, the skirt portion 46 may be in direct contact with either the neck 27 of the bottle 26 or wall portion 60. In the preferred embodiment, the rib portions 50 and 52 form a barrier for retaining the neck 27, threads 64 and stopper 28 in a sterile state. Accordingly, the permeable membrane 32 is held in place over the stopper 28 by being formed integrally with the connecting section 34, which in turn is formed integrally with the skirt portion 46 which is frictionally engaged with the outer portion 60 of the bottle 26.

3030

Den gennembrydelige membran 32's ydre overflade er beskyttet og holdes i en steril tilstand ved hjælp af et afskraldeligt, klæbende segl 66. Forløbende rundt om skørtdelen 46 findes en ring af skraldetænder 44, der forhindrer, at systemet 10 fjernes fra en fluidlimkilde 16 (fig. 2 og 7). Medens skral de tændter 44 er vist i forbindelse med den foretrukne udførelsesform er deres tilstedeværelse ikke af kritisk betydning for den foreliggende opfindelses funktion.The outer surface of the permeable membrane 32 is protected and maintained in a sterile state by a peelable adhesive seal 66. A ring of garbage teeth 44 is provided around the skirt portion 46 to prevent the system 10 from being removed from a fluid adhesive source 16 (FIG. 2 and 7). While peeling the lights 44 are shown in connection with the preferred embodiment, their presence is not critical to the function of the present invention.

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Flasken 26's bund 62 og nedre sektion af vægparten 60 er beskyttet af en svøbdel 54, der er konstrueret til mekanisk at gå i indgreb med skørtdelen 46. Medens svøbdelen 54 er vist i forbindelse med den foretrukne udførelsesform for systemet 5 10, er dets tilstedeværelse ikke af kritisk betydning for opfindelsens funktionsduelighed. Endvidere vises et aftrappet indgreb 53 mellem svøbdelen 54 og skørtdelen 46, men enhver egnet fremgangsmåde til at sammenpasse skørtdelen 46 og svøbdelen 54, såsom en tunge og en rende, kan benyttes. Svøbdelen 10 54 har en i ét dermed formet opsvingelig ophængningspart 22, der kan benyttes til at hænge systémet 10, som vist i fig.The bottom 62 and bottom section of the bottle 26 of the wall portion 60 is protected by a wrapper 54 which is mechanically engaged with the skirt portion 46. While the wrapper portion 54 is shown in connection with the preferred embodiment of the system 510, its presence is not of critical importance for the functionality of the invention. Further, a stepped engagement 53 is shown between the wrapper portion 54 and the skirt portion 46, but any suitable method of matching the skirt portion 46 and the scoop portion 54, such as a tongue and a gutter, may be used. The wrap portion 10 54 has a pivotable suspension portion 22 formed in one, which can be used to hang the system 10, as shown in FIG.

2. Selvom ophængningsorganet 22 er vist som en ring, kan enhver hensigtsmæssig konstruktion benyttes. En klinkekrog 98 kan anbringes på ophængningsorganet 22 for at lette systemet 10's 15 ophængning, således som vist i fig. 2. Klinkekrogen 98 er i indgreb med svøbdeien 54's bund, når ophængningsorganet 22 svinges væk fra flasken 26's bund 62, som vist ved punktstreg i fig. 4.2. Although the suspension means 22 is shown as a ring, any suitable construction can be used. A latch hook 98 may be mounted on the suspension means 22 to facilitate the suspension of the system 10, as shown in FIG. 2. The latch hook 98 engages the bottom of the wrapper dough 54 as the suspension means 22 is pivoted away from the bottom 62 of the bottle 26, as shown by the dash in FIG. 4th

20 Etiketten 48 kan benyttes til at holde svøbdelen 54 i mekanisk indgreb 53 med skørtdelen 46 ved at anbringe etiketten 48's klæbeside i berøring med skørtdelen 46 og svøbdelen 54. Alternativt friktionsmæssigt indbyrdes indgreb såsom et gevindmæssigt indgreb eller klæbemiddel ved indgrebsstedet 53 kan 25 benyttes til at holde svøbdelen 54 i kontakt med skørtdelen 46.The label 48 can be used to hold the wrapping member 54 in mechanical engagement 53 with the skirt portion 46 by contacting the adhesive side of the label 48 with the skirt portion 46 and the wrapping member 54. Alternatively frictional engagement such as a threaded engagement or adhesive at the engagement site 53 can be used to keeping the wrapper portion 54 in contact with the skirt portion 46.

I en anden udførelsesform for medicinleveringssystemet ifølge opfindelsen, somvist i fig. 9 er der benyttet henvisningstal 30 i "100"-serien for at angive de dele, der har en tilsvarende konstruktion, funktion og placering som delene i den foretrukne udførelsesform.In another embodiment of the drug delivery system according to the invention, as shown in FIG. 9, reference numeral 30 in the "100" series is used to designate the parts having a similar construction, function and location as the parts of the preferred embodiment.

I den alternative udførelsesform 110 benyttes en trækring 35 141 til at påføre mekanisk kraft til at adskille den gennembry delige membran 132 fra forbindelssektionen 134 langs afrivnings-li'hien 138. Krogorganer 155 går i indgreb med fremspring 157 8In the alternative embodiment 110, a pull ring 35 141 is used to apply mechanical force to separate the breakthrough membrane 132 from the connecting section 134 along the tear-off line 138. Hook members 155 engage projections 157 8.

DK 162922 BDK 162922 B

på skørtdelen 146 for at holde svøbdelen 154 i mekanisk indgreb med skørtdelen 146 og på plads over flasken 126's vægpart 160.on the skirt portion 146 to hold the wrapper portion 154 in mechanical engagement with the skirt portion 146 and in place over the wall portion 160 of the bottle 126.

5 Systemet 10*s anvendelse med en sprøjte 12 er vist i fig.5 The system 10 * s use with a syringe 12 is shown in FIG.

5. Dette opnås ved at fjerne det afskrællelige klæbende segl 66 (fig. 4) og indføre kanylen 13 gennem den gennembrydelige membran 32. Efter at have passeret den gennembrydelige membran 32, vil kanylen 13 passere gennem forsænkningen 30 i proppen 10 28, før den passerer gennem proppen 28's bundpart og den kommer ind i flasken 26's indre, der indeholder medicinen 56. Hvis medicinen 56 er pulverformet, kan diluenda indeholdt i sprøjten 12's beholder 11 tilføres gennem kanylen 13 til flasken 26's indre, hvorved medicinen 56rs udtrækning op i sprøjten 12's *5 beholder 11 bliver muligt, når medicinen 56 er blevet opløst i diluenda. Hvis medicinen 56 er i flydende form, kan den direkte suges op fra flasken 26's indre og op i sprøjten 26's beholder 11.5. This is accomplished by removing the peelable adhesive seal 66 (Fig. 4) and inserting the cannula 13 through the permeable membrane 32. After passing through the permeable membrane 32, the cannula 13 will pass through the recess 30 into the plug 10 28 before passes through the bottom portion of the stopper 28 and enters the interior of the bottle 26 containing the drug 56. If the drug 56 is powdery, diluents contained in the container 11 of the syringe 12 can be applied through the cannula 13 to the inner of the bottle 26, thereby extending the drug 56's into the syringe 12 * 5 container 11 becomes possible when drug 56 has been dissolved in diluents. If the drug 56 is in liquid form, it can be directly sucked up from the interior of the bottle 26 and into the container 11 of the syringe 26.

2020

Systemet 10's foretrukne funktionsmåde er vist i fig. 6, 7 og 8. En fligdel 42, der er formet som en del af afrivningsstrimmelen 40 gribes af fingrene 14 og trækkes væk fra skørtdelen 46. Ved denne aftrækning vil afrivningsstrimmelen 40 blive skrællet væk fra flasken 26's hals 27 ved, at den afskæres 25 fra forbindelsesparten 34 og skørtdelen 46 ved de skrøbelige sektioner eller indsnit 36 og 38. Når først afrivningsstrimmelen 40 er blevet fuldstændigt fjernet fra skørtdelen 46 og forbindelsessektionen 34 er der intet tilbage til at holde den gennembrydelige membran 32 i sin placering over proppen 28 og 30 den vil dérfor eventuelt blive fjernet fra systemet 10.The preferred mode of operation of the system 10 is shown in FIG. 6, 7 and 8. A tab portion 42 formed as part of the tear strip 40 is gripped by the fingers 14 and pulled away from the skirt portion 46. In this peel, the tear strip 40 will be peeled away from the neck 27 of the bottle 26 by cutting it 25. from the connecting portion 34 and the skirt portion 46 at the fragile sections or incisions 36 and 38. Once the stripping strip 40 has been completely removed from the skirt portion 46 and the connecting section 34, there is nothing left to hold the pervious membrane 32 in position over the plugs 28 and 30. will therefore be optionally removed from system 10.

Som vist i fig. 7 kan flasken 26's hals 27 nu indsættes i en port eller muffe 84 i fluidumkilden 16, der typisk er en fleksibel pose, der delvis er fyldt med diluenda. Flasken 3 5 26's og muffen 84's indbyrdes indgreb opnås ved gevindmæssigt indgreb mellem gevindene 64 og komplementære gevind 65 i muffen 84. Drejning af flasken 26 i forhold til fluidumkilden 16As shown in FIG. 7, the neck 27 of the bottle 26 can now be inserted into a port or sleeve 84 in the fluid source 16, which is typically a flexible bag partially filled with diluents. The mutual engagement of the bottle 26 and the sleeve 84 is obtained by threaded engagement between the threads 64 and complementary threads 65 of the sleeve 84. Rotation of the bottle 26 relative to the fluid source 16

DK 162922 BDK 162922 B

9 medfører, at halsen 27 trækkes ned i muffen 84. Dette træk får fremspring 78 fra hætten 68 på muffen 84 til at træde ind i proppen 28's forsænkning 30. Når fremspringet 78 er kommet helt ind i forsænkningen 30, vil fremspringet 78's 5 læbe 80 være i en stilling over proppen 28's kant 82. Skraldetænderne 84 går i indgreb med kompatible skraldetænder 45 i muffen 84. De kompatible skraldetænder 44 og 45's hældninger er sådan, at systemet 10 ikke kan skrues tilbage ud af muffen 84, når først det indbyrdes indgreb er påbegyndt. Hætten 10 68 er i tætnende indgreb med muffen 84's bund ved hjælp af en O-ring 76's kompression og ved læben 72's mekaniske indgreb over et fremspring 74 på muffen 84's bund.9 causes the neck 27 to be pulled down into the sleeve 84. This feature causes the projection 78 of the cap 68 of the sleeve 84 to enter the recess 30 of the plug 28. When the projection 78 has fully entered the recess 30, the projection 78 of the lip 78 be in a position above the edge 82 of the plug 28. The garbage teeth 84 engage with compatible garbage teeth 45 in the sleeve 84. The slopes of the compatible garbage teeth 44 and 45 are such that the system 10 cannot be unscrewed from the sleeve 84 once it is engaged. has begun. The cap 10 68 is sealingly engaged with the bottom of the sleeve 84 by the compression of an O-ring 76 and by the mechanical engagement of the lip 72 over a protrusion 74 on the bottom of the sleeve 84.

Når først systemet 10 er på plads i fluidumkilden 16 kan medici-15 nen 56 blandes med diluenda 86, som vist i fig. 8. Ved at benytte væskekilden 16's fleksible egenskaber kan brugeren gribe hætten 68's flange 70. Ved at gøre dette kan brugeren så manipulere hætten 68, således at læben 72 glider over fremspringet 74 og derved fjerne hætten 68 fra dens mekaniske 20 indgreb med muffen 84's bund. Når hætten 68 fjernes fra muffen 84, vil læben 80's mekaniske indgreb på fremspringet 78 mod et fremspring 82 på proppen 28 få proppen til at blive fjernet sammen med hætten 68. Denne manipulering af kombinationen bestående af hætten 68 og proppen 28 vil skabe en åben vej 26 gennem flaskeåbningen 58, således at medicinen kan blandes med diluenda 86. Diluenda 86 og medicin 56 kan yderligere blandes ved at klemme væskekilden 16's sider. Derpå kan ophængningsorganet 22 svinges op og væk fra flasken 26's bund og benyttes til at hænge fluidumkilden på en krog 24 på en stang 30 23 for intravenøs indgift, se fig. 2. Ophængningsorganet 22 holdes på plads ved at klinke-krogen 98 ved ophængningsorganet 22's basis er i indgreb med svøbdelen 54's bundpart. Rør eller slanger 18 og kateteret eller kanylen 20 (fig. 2) placeres i fluidumforbindelse med fluidumkilden 16's indre, når først 35 hætten 96 er fjernet fra portindsatsen 94.Once system 10 is in place in fluid source 16, drug 56 can be mixed with diluent 86 as shown in FIG. 8. Using the flexible properties of the liquid source 16, the user can grip the flange 70 of the cap 68. By doing this, the user can then manipulate the cap 68 so that the lip 72 slides over the projection 74, thereby removing the cap 68 from its mechanical engagement with the bottom of the sleeve 84. . When the cap 68 is removed from the sleeve 84, the mechanical engagement of the lip 80 on the projection 78 against a projection 82 on the plug 28 causes the plug to be removed together with the cap 68. This manipulation of the combination consisting of the cap 68 and the plug 28 will create an open path. 26 through the bottle opening 58 so that the medicine can be mixed with diluenda 86. Diluenda 86 and medicine 56 can be further mixed by squeezing the sides of the liquid source 16. Then, the suspension means 22 can be pivoted up and away from the bottom of the bottle 26 and used to hang the source of fluid on a hook 24 of a rod 30 23 for intravenous administration, see FIG. 2. The suspension means 22 is held in place by the latching hook 98 at the base of the suspension means 22 engaging the bottom portion of the wrapper 54. Tubes or tubes 18 and the catheter or cannula 20 (Fig. 2) are placed in fluid communication with the interior of the fluid source 16 once the cap 96 is removed from the port insert 94.

Skulle man ønske at indgive to lægemidler samtidigt, kan et andet lægemiddel tilsættes til flasken 26 ved at benytte enShould it be desired to administer two drugs simultaneously, another drug may be added to the bottle 26 using a

DK 162922 BDK 162922 B

10 sprøjte 12, før afrivningsstrimmelen 40 fjernes for at benytte systemet 10 med fluidumkilden 16. I den situation hvor efter ordre blandede lægemidler kræves, kan tomme medicinflasker leveres og så senere fyldes med den beordrede lægemiddelblan-5 ding for midlertidig lagring før senere brug ved en fluidumkilde eller en fleksibel lagerbeholder for fluida.10 syringe 12 before removing the stripping strip 40 to use the system 10 with the fluid source 16. In the situation where orderly mixed drugs are required, empty vials can be delivered and then later filled with the ordered drug mixture for temporary storage before later use at fluid source or a flexible fluid storage container.

Den anden udførelsesform 110 betjenes i det væsentlige på samme måde som den foretrukne udførelsesform 10. Den gennembry-10 delige membran 132 adskilles imidlertid fra skørtdelen 146 ved hjælp af en trækring 141 i stedet for ved afrivningsstrimmefen 40 (fig. 6). Desuden er flasken vist med en ikke gevindskåren afslutning til brug for det tilfælde, hvor der ikke benyttes noget gevindmæssigt indgreb såsom en snap- eller friktionspas-15 ning.However, the second embodiment 110 is operated substantially in the same manner as the preferred embodiment 10. However, the permeable membrane 132 is separated from the skirt portion 146 by a pull ring 141 instead of the tear strip 40 (Fig. 6). In addition, the bottle is shown with a non-threaded end for use in the case where no threaded engagement such as a snap or friction fit is used.

Systemerne 10 og 110 fremstilles på i det væsentlige samme måde. Medicinen 56 indføres først i flasken 26. Derpå anbringes proppen 128 på plads i flasken 26's åbning 58. Derpå placeres 20 skørtdelen 46 over flasken 26, således at den gennembrydelige membran 32 er placeret over proppen 28 og forseglingsringene 50 og 52 er i friktionsmæssigt indgreb med flasken 26's vægpart 60. Når dette først er i korrekt position, vil afrivningsstrimmelen 40 forløbe rundt om flasken 26's hals. Derpå placeres 25 svøbdelen 54 over vægparten 60's bund og forskydes yderligere til mekanisk indgreb ved 53 med skørtdelen 46. Derpå lægges etiketten 48 rundt om skørtdelen 46 og svøbdelen 54, således at skørtdelen 46 og svøbdelen 54 holdes tæt op mod hinanden.Systems 10 and 110 are produced in substantially the same way. The medicine 56 is first introduced into the bottle 26. Then the stopper 128 is placed in place in the opening 58 of the bottle 26. Then the skirt portion 46 is placed over the bottle 26 so that the permeable membrane 32 is placed over the stopper 28 and the sealing rings 50 and 52 engage in frictional engagement with the bottle. the wall portion 60 of the bottle 26. Once in the correct position, the stripping strip 40 will extend around the neck of the bottle 26. Then the wrapper portion 54 is placed over the bottom of the wall portion 60 and is further displaced for mechanical engagement at 53 with the skirt portion 46. Then, the label 48 is placed around the skirt portion 46 and the wrapper portion 54 so that the skirt portion 46 and the wrapper portion 54 are held close together.

30 Som vist i fig. 7 og 8 er muffen 84 typisk som en dorn forseglet ved henvisningstallet 90 til væskekilden 16's kant på tilsvarende måde som indgiftporten 88 i form af en dorn er forseglet ved henvisningstallet 92 til en anden part af væskekilden eller den fleksible beholder 16. Systemet 10's skørtdel 46, 35 afrivningsstrimmel 40, forbindelsespart 34, og gennembrydelige membran 32 er typisk fremstillet af polypropylenplast, hvilket30 As shown in FIG. 7 and 8, the sleeve 84 is typically sealed as a mandrel at the reference numeral 90 to the edge of the fluid source 16 in a manner similar to the entry port 88 in the form of a mandrel sealed at the reference numeral 92 to another portion of the fluid source or flexible container 16. The skirt portion 46 of the system 10 , 35 tear strip 40, connector part 34, and permeable membrane 32 are typically made of polypropylene plastic, which

Claims (15)

1. Lager- og leveringssystem for en substans, der kan strømme, og omfattende en lille medicinflaske (26) med en åbning (58), en vægpart (60) og en bund (62), en aftagelig prop (28) i tæt-35 nende indgreb med åbningen (58), og en membran (32) anbragt over proppen (28), kendetegnet ved, at både proppen (28) og membranen (32) er gennembryde 1 ige, en skørtdel (46) DK 162922 B er i friktionsmæssigt indgreb med flaskens (26) vægpart (60), og et svækket organ (34) forbinder membranen (32) med skørtdelen (46), hvorved membranen også kan fjernes fra sin placering over proppen (28) ved at bryde eller fjerne den svækkede part 5 (34).A flow and delivery system for a flowable substance comprising a small medicine bottle (26) with an opening (58), a wall portion (60) and a bottom (62), a removable plug (28) in a sealed container. 35, and a diaphragm (32) disposed over the plug (28), characterized in that both the plug (28) and the diaphragm (32) are perforated, a skirt portion (46) DK 162922 B being in frictional engagement with the wall portion (60) of the bottle (26), and a weakened member (34) connects the diaphragm (32) to the skirt portion (46), whereby the diaphragm can also be removed from its location over the stopper (28) by breaking or removing it weakened party 5 (34). 2. System ifølge krav 1, kendetegnet ved, at flaskeåbningen (58), den aftagelige, gennembrydelige prop (28) og flaskens (26) vægpart (60) indesluttet ved hjælp af organet 10 til at fastgøre den aftagelige gennembrydelige membran (32) til skørtdelen (46) er holdt i en steril tilstand.System according to claim 1, characterized in that the bottle opening (58), the removable, transparent stopper (28) and the wall portion (60) of the bottle (26) are enclosed by means 10 for attaching the removable transparent membrane (32) to the the skirt portion (46) is kept in a sterile state. 3. System ifølge krav 1 eller 2, kendetegnet ved, at organet til at forbinde den aftagelige, gennembrydelige membran (32) med skørtdelen (46) er omsluttet af mindst én 15 svækket sektion (36).System according to claim 1 or 2, characterized in that the means for connecting the removable, permeable membrane (32) with the skirt part (46) is enclosed by at least one weakened section (36). 4. System ifølge krav 1, 2 eller 3, kendetegnet ved, at den aftagelige, gennembrydelige membran (32) holdes i steril tilstand ved at være dækket med en afpilleligt klæbende 20 forsegling (66).System according to claim 1, 2 or 3, characterized in that the removable, permeable membrane (32) is kept in a sterile state by being covered with a peelable adhesive seal (66). 5. System ifølge krav 1, 2 eller 3, kendetegnet ved, at skørtdelens (46) friktionsmæssige indgreb med flaskens (26) vægpart (60) tilvejebringes ved hjælp af mindst en ribbe- 25 del (50).System according to claim 1, 2 or 3, characterized in that the frictional engagement of the skirt part (46) with the wall part (60) of the bottle (26) is provided by at least one rib part (50). 6. System ifølge et eller flere af ovenstående krav, kendetegnet ved, at svækningsorganet (34) er omsluttet af en skrøbelig part (36) konstrueret og arrangeret til at fast- 30 gøre den aftagelige gennembrydelige membran (32) til skørtdelen, og at en svøbdel (54) dækker den sektion af flaskens (26) vægpart (60), der ikke er dækket af skørtdelen (48), og hvor organer (22) til at ophænge lagrings- og dispenseringssystemet er formet som en del af svøbdelen (54). 35System according to one or more of the preceding claims, characterized in that the weakening means (34) is enclosed by a fragile part (36) constructed and arranged to attach the removable permeable membrane (32) to the skirt part and cover (54) covers the section of the wall portion (60) of the bottle (26) which is not covered by the skirt (48) and wherein means (22) for suspending the storage and dispensing system are formed as part of the cover (54) . 35 7. System ifølge krav 1, 2, 3, 5 eller 6, kendetegnet ved, at det i kombination med dette omfatter en fleksi- DK 162922 B bel f 1 uidumbeholder (16) med en port (84), og at skørtdelen (46) og porten (84) i den fleksible beholder (16) har komplementære skraldetænder (44, 45).System according to claims 1, 2, 3, 5 or 6, characterized in that it comprises in combination with a flexible container (16) with a port (84) and the skirt part (46). ) and the port (84) of the flexible container (16) has complementary garbage teeth (44, 45). 8. System ifølge krav 1 eller 2, kendetegnet ved, at proppen (28) har en forsænkning (30) konstrueret og anbragt til at gå i indgreb med organer til at fjerne proppen fra flasken (26).System according to claim 1 or 2, characterized in that the stopper (28) has a recess (30) constructed and arranged to engage means for removing the stopper from the bottle (26). 9. System ifølge krav 1, 2, 5, 6 eller 8 i kombination med en fluidumbeholder (16) med en port (84) og et flaskeindgrebsorgan, kendetegnet ved, at flasken (26) har komplimentære indgrebsorganer hvorved fluidumforbindelsen mellem flaskens (26) indre og fluidumbeholderens (16) indre opnås ved 15 indbyrdes indgreb mellem flasken (26) og porten (84) i fluidumbeholderen (16).System according to claims 1, 2, 5, 6 or 8 in combination with a fluid container (16) with a port (84) and a bottle engaging means, characterized in that the bottle (26) has complementary engaging means whereby the fluid connection between the bottle (26) the interior of the fluid reservoir (16) is obtained by mutual engagement between the bottle (26) and the port (84) of the fluid reservoir (16). 10. System ifølge krav 1, 2, 5, 6, 8 eller 9 i kombination med en fluidumbeholder (16) med en port (84) og gevindskårne orga- 20 ner (65) til indgreb med en flaske (26) i forbindelse med porten (84), kendetegnet ved, at flasken (26) har komplementære gevindskårne dele (84) hvorved i ndbyrdes indgreb mellem åbningen (58) i flasken (26) og porten (84) i fluidumbeholderen (16) opnås ved hjælp af de komplementære gevind-25 skårne organer (64, 65).System according to claims 1, 2, 5, 6, 8 or 9 in combination with a fluid container (16) having a port (84) and threaded means (65) for engaging a bottle (26) in connection with the port (84), characterized in that the bottle (26) has complementary threaded portions (84), thereby interposing between the opening (58) of the bottle (26) and the port (84) of the fluid container (16) by means of the complementary thread-cut notches (64, 65). 11. System ifølge krav 1, 2 eller 8, kendetegnet ved, at det endvidere omfatter en kanyle (18, 20) indsat i flasken (26) gennem membranen (32) og gennem proppen (28) 30 hvorved den strømbare substans kan trækkes ud fra flasken (26).System according to claim 1, 2 or 8, characterized in that it further comprises a cannula (18, 20) inserted into the bottle (26) through the diaphragm (32) and through the stopper (28) 30 whereby the flowable substance can be withdrawn. from the bottle (26). 12. System ifølge krav 1, 3 eller 6, kendetegnet ved, at organet (34) til at forbinde membranen (32) med skørt- 35 delen (46) omsluttes af to skrøbelige sektioner (36, 38) med en derimellem placeret flig (42). DK 162922 BSystem according to claim 1, 3 or 6, characterized in that the means (34) for connecting the diaphragm (32) to the skirt part (46) is enclosed by two fragile sections (36, 38) with a tab located therebetween ( 42). DK 162922 B 13. System ifølge krav 6, kendetegnet ved, at svøbdelen (54) og skørtdelen (46) er forbundet ved hjælp af en etiket (48) med klæbemiddel på én side, hvilket klæbemiddel er i berøring med svøbdelen (54) og skørtdelen (46). 5System according to claim 6, characterized in that the wrapper part (54) and the skirt part (46) are connected by means of a label (48) with adhesive on one side, which adhesive is in contact with the wrapper part (54) and the skirt part (46). ). 5 14. System ifølge krav 9, kendetegnet ved, at det indbyrdes indgreb mellem flasken (26) med porten (84) i fluidumbeholderen (16) opnås ved relativ drejningsmæssigt indgreb mellem indgrebsorganet (64) og det komplementære indgrebsorgan 10 (65), og at systemet fortrinsvis endvidere ombefatter komple mentære skraldeorganer (44) på porten (84) og flasken (26) for indbyrdes indgreb ved relativ drejningsmæssigt indgreb, hvorved flaskens (26) frigørelse fra fluidumbeholderen (16) forhi ndres. 15System according to claim 9, characterized in that the mutual engagement of the bottle (26) with the port (84) in the fluid container (16) is achieved by relative rotational engagement between the engaging means (64) and the complementary engaging means 10 (65). the system preferably further comprises complementary ratcheting means (44) on the port (84) and the bottle (26) for relative engagement by relative rotational engagement, thereby preventing the release of the bottle (26) from the fluid container (16). 15 15. System ifølge krav 1 og 14, kendetegnet ved, at skraldeorganet (44) på flasken (26) er defineret af fremspring på skørtdelen (46). 20 25 30 35System according to claims 1 and 14, characterized in that the ratchet (44) on the bottle (26) is defined by projections on the skirt part (46). 20 25 30 35
DK104485A 1984-03-19 1985-03-07 STORAGE AND DELIVERY SYSTEM, ISAES FOR MEDICINE DK162922C (en)

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US59060184 1984-03-19

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EP (1) EP0155560B1 (en)
JP (1) JPS60210261A (en)
KR (1) KR920000436B1 (en)
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AU (1) AU591055B2 (en)
CA (1) CA1261700A (en)
DE (1) DE3581222D1 (en)
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GR (1) GR850670B (en)
IE (1) IE57676B1 (en)
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KR920000436B1 (en) 1992-01-14
DK104485D0 (en) 1985-03-07
KR850006143A (en) 1985-10-02
JPH0226506B2 (en) 1990-06-11
IL74577A0 (en) 1985-06-30
NZ211234A (en) 1988-07-28
US4614515A (en) 1986-09-30
AU3970985A (en) 1985-09-26
ATE59773T1 (en) 1991-01-15
DK162922C (en) 1992-05-25
AU591055B2 (en) 1989-11-30
JPS60210261A (en) 1985-10-22
ES292869U (en) 1986-08-01
IL74577A (en) 1992-01-15
DE3581222D1 (en) 1991-02-14
DK104485A (en) 1985-09-20
ES289794Y (en) 1986-10-16
CA1261700A (en) 1989-09-26
ES292869Y (en) 1987-04-16
IE850431L (en) 1985-09-19
ZA851412B (en) 1985-10-30
EP0155560A2 (en) 1985-09-25
GR850670B (en) 1985-07-16
EP0155560B1 (en) 1991-01-09
EP0155560A3 (en) 1987-06-24
ES289794U (en) 1986-03-01
IE57676B1 (en) 1993-02-24

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